MELARSOPROL injectable

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    Prescription under medical supervision

     

    Therapeutic action

    • Trypanocide (arsenical derivative)

    Indications

    • Meningoencephalitic stage of African trypanosomiasis due to T. b. gambiense and T. b. rhodesiense

    Forms and strengths, route of administration

    • 180 mg in 5 ml ampoule (36 mg/ml), 3.6 % solution in propylene glycol, for slow IV injection.
      NEVER BY IM OR SC INJECTION.

    Dosage and duration

    Patients must be treated in hospital, under close medical supervision.

    • Child and adult: 2.2 mg/kg (max. 5 ml) once daily for 10 days

    Contra-indications, adverse effects, precautions

    • May cause:
      • reactive encephalopathy (5-10% of cases): repeated or prolonged seizures, coma, psychical disorders, usually between the 5th and the 8th day of the ten-day treatment (but sometimes later, even after the patient has been discharged) or just before/during the 2nd course of the intermittent treatment;
      • arsenical reactions: headache, fever, tachycardia, hypertension, jaw pain, neurological disorders (hyperreflexia);
      • gastrointestinal disturbances, skin reactions (exfoliative dermatitis, urticaria), peripheral neuropathy, haematological disorders (haemolytic anaemia in patients with G6PD deficiency, agranulocytosis), hepatic or renal impairment, myocardial damage;
      • swelling, pain, phlebitis, venous sclerosis, necrosis at injection site in the event of extravasation during IV administration.
    • Use a completely dry syringe: the solution precipitates in presence of water. As propylene glycol can dissolve plastic, the drug should preferably be administered using a glass syringe (only if sterilisation is reliable), otherwise inject immediately (but slowly) using a plastic syringe.
    • Pregnancy: CONTRA-INDICATED

    Remarks

    • Oral prednisolone is frequently associated during the course of treatment.
    • For the meningoencephalitic stage of gambiense trypanosomiasis, the treatment of choice is nifurtimox + eflornithine (NECT).

    Storage

     
    – Below 25 °C